Following an informal heads-up on 25 March 2020, today the European Commission adopted a proposed regulation to postpone by one year the date of application of the Medical Devices Regulation (Regulation (EU) 2017/745, “MDR”). If enacted, the Medical Device Directive (Directive 93/42/EEC) and implementing legislation of the EU member states will continue to apply as far as they have not yet been amended. The proposed measure would come as an immense relieve to the medical device industry, especially small and medium players, as several of the challenging requirements to be introduced by the MDR would not apply until May 2021.
Moreover, the proposed regulation anticipates the possible derogation from the conformity assessment procedures of medical devices. In a nutshell, the proposal allows member states to authorize the placing on the market of medical devices for which the applicable conformity assessment procedures have not been carried out but the use of which is in the interest of public health or patient safety. Such derogation, clearly intended to tackle the challenges raised by the COVID-19 outbreak, would be immediately and directly applicable in all EU member states if the proposed regulation is enacted.
A postponement would have a significant impact on the medical devices industry as the different stakeholders (including economic operators and authorities) have been working hard during the past two years to prepare for implementation by May 2020. However, it could also be seen as an opportunity for the industry as it will:
- Provide extra time for the designation of the Notified Bodies. From DLA Piper’s experience, the designation process was more time consuming and complex than initially foreseen by the Commission, probably because of the need to involve assessors from both EU and national authorities. Because of the complexities, several Notified Bodies decided to discontinue their activities under the new MDR. Thus, manufacturers often had problems to actually find Notified Bodies to comply with the new requirements under MDR.
- Allow manufacturers to keep the current classifications of their medical devices and rely on the existing processes assessing the classification. Namely, the rules for reprocessing Class I devices will not change (no involvement of Notified Bodies). Also, the additional rules for classifying medical devices will not have to be applied until end of May 2021.
- Postpone the implementation of the rules regarding the unique device identification (UDI) system. This will give the national legislative bodies more time to implement the required national laws for encouraging the UDI system, while not even a draft legislation is in place in several member states. Also, manufacturers will currently have additional time for implementing the UDI system and thus will have time to concentrate on other issues. Of course, the unavailability of EUDAMED which would have been an issue for the UDI system becomes less of a concern in case of postponement.
DLA Piper’s lawyers have been advising manufacturers of all business areas in regards of the new MDR over past years. Thus, we can provide seamless and coordinated answers to all of your questions related to the new MDR, as well the proposed implementation’s postponement. We will continue to monitor the developments and remain available – for further information please do not hesitate to contact us or your usual DLA Piper person.